NCT05194618

Efficacy and Safety of Valerian Root Extract and Lavender Essential Oil Combination, Over 4 Weeks in Subjects With Sleep Complaints

A Randomized, Double-blind, Parallel Groups, Placebo-controlled, Proof-of-concept Study to Assess the Efficacy and Safety of Valerian Root Extract and Lavender Essential Oil Combination in Subjects With Sleep Complaints.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Several epidemiologic studies have clearly shown that sleep complaints are very common in the general population. It involves a predominant complaint of a nonrestorative sleep or dissatisfaction with sleep quality or duration and it is accompanied by difficulties in initiating sleep at bedtime, frequent or prolonged awakenings, or early-morning awakening with an inability to return to sleep. Lavender oil as well as valerian officinalis are benefiting from a long traditional use in sleep and these products have moderate sedative effects compared to classical hypnotic compounds. This study is proposed to assess the efficacy and the safety of this combination in subjects with slight to moderate sleep complaints.

Detailed description

Several epidemiologic studies have clearly shown that sleep complaints are very common in the general population. It involves a predominant complaint of a nonrestorative sleep or dissatisfaction with sleep quality or duration and it is accompanied by difficulties in initiating sleep at bedtime, frequent or prolonged awakenings, or early-morning awakening with an inability to return to sleep. In a representative sample of the French population, 73% of subjects indicated the presence of a nocturnal sleep problem during the preceding month and can be considered as poor sleepers. Fifty-seven percent complained of difficulties initiating sleep 53 % complained of night awakenings, and 41 % complained of a nonrestorative sleep. Only 29% of the sample had sleep problems that would meet the diagnostic criteria for insomnia disorders defined in Diagnostic and Statistical Manual of Mental Disorders 5 (DSM5), the classification of mental disorders of the APA as difficulty to initiate or maintain sleep at least 3 times a week and for at least 3 consecutive months. Moreover, the prevalence of poor sleepers has been massively increased in the recent epidemic context. Poor sleep is associated with increased fatigue, psychological distress, risk of suicide, higher medical costs, increased disability, and greater limitations of activity. Poor sleepers, excluding individuals with sleep-disordered breathing, other significant medical conditions and psychiatric disorders, have a potentially serious health impact. An analysis of 28 epidemiological studies found that sleep complaints are associated with psychological complaints, emotional fluctuations, alcohol and drug abuse. Health-related quality of life is nearly always affected in subjects experiencing sleep complaints (difficulty initiating or maintaining sleep), according to the findings of the large Sleep Heart Health Study. Poor sleepers still require a medical attention. Non-medicinal methods are particularly indicated in poor sleepers: sleep hygiene advice, relaxation, restriction of time spent in bed, and cognitive-behavioural therapies that combine these approaches. In poor sleepers, use complementary health approaches such as herbal to promote or maintain sleep must also receive the most research attention. As single ingredients, valerian officinalis root extract has been identified as having clinical evidence to demonstrate improvement in insomnia complaints: * Sleep onset latency * Night awakenings * Sleep quality * Sleep efficiency Studies have also demonstrated that Lavandula angustifolia essential oil had a beneficial effect on anxiety and disturbed sleep. Lavender oil as well as valerian officinalis are benefiting from a long traditional use in sleep and these products have moderate sedative effects compared to classical hypnotic compounds. The existing published clinical trials as well as the traditional use suggest a positive effect on sleep and stress, however Valerian aqueous extract and lavender essential oil have been studied in the past for different dosages, for small simple size and standalone only. Therefore it is difficult to fully rely on the past literature to estimate the potential effect of the combination Valerian - Lavender Essential Oil, that explain the purpose of this proof of concept study which aim to better quantify the effect of the combination on sleep complaints compared to a placebo group in the targeted population. This study is proposed to assess the efficacy and the safety of this combination in subjects with slight to moderate sleep complaints.

Conditions

• Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Valerian - lavender	1 tablet per day, half hour before bedtime, day 1 to day 28
DIETARY_SUPPLEMENT	Placebo	1 tablet per day, half hour before bedtime, day 1 to day 28

Timeline

• Start date: 2022-02-02
• Primary completion: 2023-03-02
• Completion: 2023-03-02
• First posted: 2022-01-18
• Last updated: 2023-03-14

Locations

1 site across 1 country: France